• Information on how to submit electronic applications within MRP, DCP and National procedures via the CESP portal is found on the CESP (hma.eu) website.

• CMDh Best Practice Guide on the use of eCTD in the MRP/DCP (April 2020) [Track version]

• Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National Procedures (July 2024) [Track version]

• Requirements on submissions for Variations and Renewals within MRP and National Procedures (July 2024) [Track version]

Questions & Answers on eSubmissions

• Question and answer document covering practical issues for variations in eCTD format

• Q&A on how to handle ongoing procedures in relation to mandatory eCTD format

• Q&A on mandatory eCTD in National Procedures (NP)